FDA Adverse Event
Other
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 2450917
·
Received February 9, 2012
Report
- Report Number
- 2135225-2012-00019
- Event Type
- Other
- Date Received
- February 9, 2012
- Date of Event
- December 1, 2011
- Report Date
- January 11, 2012
- Manufacturer
- MERZ AESTHETICS, INC.
- Product Code
- LMH
- PMA / PMN Number
- P050052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1022655 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THE LOT WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED. AT THE TIME OF THIS REPORT, AN UPDATE OF THE PATIENT'S SYMPTOMS HAVE NOT BEEN PROVIDED.
Description of Event or Problem · 1
ON (B)(6) 2011, A (B)(6) FEMALE PATIENT WAS INJECTED WITH 0.6 ML OF RADIESSE DERMAL FILLER IN THE NASAL BRIDGE AND TIP FOR RESHAPING. THE PATIENT SUFFERED RAPID ONSET OF CELLULITIS, REQUIRING HOSPITALIZATION AND TREATMENT WITH IV ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIESSE DERMAL FILLER | RADIESSE INJECTABLE IMPLANT | LMH | MERZ AESTHETICS, INC. | 1022655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Hospitalization |